This clinical trial is focused on studying the long-term safety and effectiveness of a treatment called plozasiran in adults with hypertriglyceridemia. Hypertriglyceridemia is a condition where there are high levels of triglycerides, a type of fat, in the blood. The treatment being tested, plozasiran, is a solution for injection that targets a specific protein in the body known as apolipoprotein C-III, which plays a role in controlling triglyceride levels.
The purpose of the study is to evaluate how safe plozasiran is for long-term use in people with hypertriglyceridemia. Participants in the study will receive injections of plozasiran and will be monitored over time to see how their triglyceride levels change. The study will also look at other factors, such as changes in cholesterol levels and any side effects that may occur during the treatment period.
Throughout the study, participants will have regular check-ups to track their health and any changes in their condition. The study aims to provide valuable information on the safety and potential benefits of plozasiran for managing high triglyceride levels in the long term. This research could help improve treatment options for individuals with hypertriglyceridemia.
1initial visit
Upon joining the study, you will attend an initial visit. During this visit, you will receive detailed information about the study and what to expect. You will also have the opportunity to ask any questions you may have.
A healthcare professional will review your medical history and conduct a physical examination to ensure you meet the study requirements.
2medication administration
You will receive the study medication, ARO-APOC3 PFS, which is a solution for injection. This medication is administered subcutaneously, meaning it is injected under the skin.
The dosage and frequency of the medication will be explained to you by the healthcare team. It is important to follow their instructions carefully.
3regular follow-up visits
You will have regular follow-up visits with the healthcare team. These visits are important to monitor your health and the effects of the medication.
During these visits, blood tests and other assessments may be conducted to evaluate your response to the treatment.
4reporting side effects
If you experience any side effects or changes in your health, it is important to report them to the healthcare team immediately.
The team will provide guidance on how to manage any side effects and ensure your safety throughout the study.
5end of study procedures
At the end of the study, you will have a final visit with the healthcare team. This visit will include a comprehensive assessment of your health and any changes that occurred during the study.
You will receive information on how to continue managing your condition after the study concludes.
Who Can Join the Study?
Must be an adult male or a nonpregnant, nonlactating adult female.
Must be able and willing to provide written consent to participate in the study.
Must have completed all required visits in a previous related study.
Female participants who can have children must agree to use a highly effective form of birth control during the study and for at least 90 days after the study ends or after the last dose of the study medication, whichever is later.
Male participants must agree to use a condom during the study and for at least 90 days after the study ends or after the last dose of the study medication, whichever is later.
Participants must not donate sperm or eggs during the study and for at least 90 days after the study ends or after the last dose of the study medication, whichever is later.
Female participants using hormonal birth control must have been stable on the medication for more than one menstrual cycle before starting the study.
Who Cannot Join the Study?
Patients with a history of allergic reactions to the study medication cannot participate. An allergic reaction is when your body has a bad response to something, like a rash or trouble breathing.
Patients who are currently taking other medications that might interfere with the study medication are not eligible. This means if you are on certain drugs that could affect how the study drug works, you cannot join.
Patients with severe liver disease cannot participate. The liver is an organ that helps clean your blood and digest food, and severe disease means it is not working well.
Patients with uncontrolled diabetes are excluded. This means if your blood sugar levels are not stable, you cannot join the study.
Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
Patients with a history of substance abuse in the past year are not eligible. Substance abuse means using drugs or alcohol in a way that is harmful to you.
Patients who have participated in another clinical trial within the last 30 days cannot join. This is to make sure that the results of this study are not affected by another study.
Plozasiran is a medication being studied for its long-term safety and effectiveness in treating adults with high levels of triglycerides in their blood, a condition known as hypertriglyceridemia. This medication is designed to help lower these triglyceride levels, which can reduce the risk of heart disease and other related health issues. The study aims to ensure that plozasiran is safe for long-term use and continues to be effective in managing triglyceride levels over time.
Hypertriglyceridemia – Hypertriglyceridemia is a condition characterized by elevated levels of triglycerides in the blood. Triglycerides are a type of fat that circulates in the bloodstream and is stored in the body’s fat tissues. This condition often develops when the body produces too many triglycerides or does not break them down efficiently. Over time, high triglyceride levels can contribute to the hardening and narrowing of the arteries, a process known as atherosclerosis. It can also lead to the development of fatty deposits in the liver and pancreas. Hypertriglyceridemia is often associated with other conditions such as obesity, diabetes, and metabolic syndrome.
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